Airway implant

ABSTRACT

A method and apparatus are disclosed for treating a condition of a patient&#39;s airway. The condition is attributed at least in part to a spacing of tissue from opposing surfaces in the airway. In one embodiment, the method and apparatus include placing a tissue contractor within the tissue. The contractor includes a static end and a tissue in-growth engaging end. The static end is secured to a bony structure adjacent to tissue to be contracted. The tissue in-growth engaging end is secured to the tissue and spaced from the bony structure. A spacing between the tissue engaging end and a bony end is contracted in order to place the tissue under tension.

I. BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention pertains to a method and apparatus for treating acondition of an upper airway of a patient. More particularly, thisinvention is directed to such a method and apparatus including animplant to improve patency of the airway.

2. Description of the Prior Art

Upper airway conditions such as obstructive sleep apnea (“OSA”) andsnoring have received a great deal of attention. These conditions haverecognized sociological and health implications for both the patient andthe patient's bed partner.

Numerous attempts have been made towards treating OSA and snoring. Theseinclude placing implants in either the tissue of the soft palate or thepharyngeal airway as disclosed in commonly assigned U.S. Pat. No.6,250,307 to Conrad et al. dated Jun. 26, 2003, U.S. Pat. No. 6,523,542to Metzger et al. dated Feb. 25, 2003 and U.S. Pat. No. 6,431,174 toKnudson et al. dated Aug. 13, 2002. Further, U.S. Pat. No. 6,601,584 toKnudson et al. dated Aug. 5, 2003 teaches a contracting implant forplacement in the soft palate of the patient.

In the '584 patent, an embodiment of the contracting implant includestwo tissue attachment ends (for example ends 102b in FIGS. 46 and 47)which are maintained in a space-apart, stretched relation by abio-resorbable member 102c which surrounds an internal spring orresilient member 102a. After implantation, tissue grows into theattachment ends 102b. The bioresorbable member 102c is selected toresorb after the tissue in-growth permitting the resilient member 102ato contract drawing ends 102b together as illustrated in FIG. 47 of the'584 patent (incorporated herein by reference). Tissue contraction isbelieved to be desirable in that the tissue contraction results in adebulking of the tissue and movement of tissue away from opposing tissuesurfaces in the pharyngeal upper airway.

Another prior art technique for treating OSA or snoring is disclosed inU.S. Pat. No. 5,988,171 to Sohn et al. dated Nov. 23, 1999. In the '171patent, a cord (e.g., a suture material) (element 32 in FIG. 6 of the'171 patent) is placed surrounding a base of the tongue and secured tothe jaw by reason at an attachment member (element 20 in FIG. 6 of the'171 patent). In the method of the '171 patent, the member 32 can beshortened to draw the base of the tongue toward the jaw and thereby movethe tissue of the base of the tongue away from the opposing tissue ofthe pharyngeal airway. However, this procedure is often uncomfortable.This procedure, referred to as tongue suspension, is also described inMiller et al., “Role of the tongue base suspension suture with TheRepose System bone screw in the multilevel surgical management ofobstructive sleep apnea”, Otolaryngol. Head Neck Surg., Vol. 126, pp.392-398 (2002).

Another technique for debulking tissue includes applying radio frequencyablation to either the tongue base or of the soft palate to debulk thetissue of the tongue or palate, respectively. This technique isillustrated in U.S. Pat. No. 5,843,021 to Edwards et al. dated Dec. 1,1998. RF tongue base reduction procedures are described in Powell etal., “Radiofrequency tongue base reduction in sleep-disorderedbreathing: A pilot study”, Otolaryngol. Head Neck Surg., Vol. 120, pp.656-664 (1999) and Powell et al., “Radiofrequency Volumetric Reductionof the Tongue—A Porcine Pilot Study for the Treatment of ObstructiveSleep Apnea Syndrome”, Chest, Vol. 111, pp. 1348-1355 (1997).

A surgical hyoid expansion to treat OSA is disclosed in U.S. Pat. No.6,161,541 to Woodson dated Dec. 19, 2000. Other tongue treatments forOSA include stimulation of the hypoglossal nerve. This procedure isdescribed in Eisle et al., “Direct Hypoglossal Nerve Stimulation inObstructive Sleep Apnea”, Arch. Otolaryngol. Head Neck Surg., Vol. 123,pp. 57-61 (1997).

II. SUMMARY OF THE INVENTION

According to a preferred embodiment to the present invention a methodand apparatus are disclosed for treating a condition of a patient'sairway. The condition is attributed at least in part to a spacing oftissue from opposing surfaces in the airway. In one embodiment, themethod and apparatus include placing a tissue contractor within thetissue. The contractor includes a static end and a tissue in-growthengaging end. The static end is secured to a bony structure adjacent totissue to be contracted. The tissue in-growth engaging end is secured tothe tissue and spaced from the bony structure. A spacing between thetissue engaging end and a bony end is contracted in order to increasethe airway geometry.

III. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation, schematic view of a patient illustratingstructure defining an upper airway of the patient and showing an implantaccording to an embodiment of the present invention positioned withinthe soft palate and secured to the bony structure of a hard palate andshowing a similar implant in the tongue and secured to the bonystructure of the jaw;

FIG. 2 is the view of FIG. 1 following contracting of the implants inthe palate and tongue;

FIG. 3 is a view similar to that of FIG. 1 and showing an alternativeembodiment of the present invention with implants of the alternativeembodiment implanted in both the soft palate and tongue;

FIG. 4 is the view of FIG. 3 showing the implants in a contracted state;

FIG. 5 is a view similar to that of FIG. 1 and showing a furtheralternative embodiment of the present invention with an implant of thefurther alternative embodiment implanted in the tongue;

FIG. 6 is the view of FIG. 5 contraction of tissue around the implant;

FIG. 7 is a top plan view of FIG. 5 showing an anterior-posterior axisA-P of the tongue;

FIG. 8 is a view similar to that of FIG. 1 and showing a yet furtheralternative embodiment of the present invention with an implants of theyet further alternative embodiment implanted in the tongue;

FIG. 9 is a view similar to FIG. 7 showing immediate post-implant of astill further embodiment of the present invention; and

FIG. 10 is the view of FIG. 9 following tissue in-growth and resorptionof bio-resorbable elements.

IV. DESCRIPTION OF THE PREFERRED EMBODIMENT

With reference now to the various drawing figures in which identicalelements are numbered identically throughout, a description of thepreferred embodiment of the present invention will now be provided. Tofacilitate a description and an understanding of the present invention,the afore-mentioned U.S. Pat. Nos. 6,250,307; 6,523,542; 6,431,174;6,601,584; 5,988,171 and 5,843,021 are hereby incorporated herein byreference.

With initial reference to FIG. 1, a soft palate SP is shown in sideelevation view extending from a bony portion of a hard palate HP. Thesoft palate SP extends rearward to a trailing end TE. FIG. 1 alsoillustrates a tongue T with a base TB opposing a pharyngeal wall PW. Ajawbone JB is shown at the lower front of the tongue T.

As a first described embodiment of the present invention, an implant 10is shown in FIG. 1 completely implanted within the tongue T. A similarimplant 10′ is fully implanted in the soft palate SP. As will beapparent, implants 10, 10′ are functionally and structurally similardiffering only in size to facilitate placement in the tongue T and softpalate SP, respectively. As a result, a description of implant 10 willsuffice as a description of implant 10′ (with similar elements similarlynumbered with the addition of an apostrophe to distinguish the implants10, 10′). Further, while both implants 10, 10′ are shown implanted inthe same patient, either could be separately implanted.

The implant 10 includes an elongated member 12 having a tissue in-growthend 14 and a static end 16. The tissue in-growth end 14 may be anytissue growth inducing material (e.g., felt or PET) to induce growth oftissue into the end 14 to secure the end 14 to surrounding tissuefollowing implantation. The elongated member 12 may be suture materialone end secured to the felt 14 and with the static end 16 being a freeend of the suture material 12.

An anchor 18 (in the form of a treaded eye-bolt) is secured to thejawbone JB. In the case of implant 10′, the anchor 18′ is secured to thebone of the hard palate. The end 16 is secured to the anchor 18.

The end 14 is placed in the tongue near the tongue base TB. A surgeonadjusts a tension of the suture 12. This causes the tongue base TB to beurged toward the jawbone JB thereby placing the tissue of the tongue incompression. When a desired tension is attained, the surgeon may tie offthe static end 16 at the bolt 18 retaining the tissue of the tongue Tunder tension. This method and apparatus provides a resistance tomovement of the tongue base TB toward the pharyngeal wall PW. Similarly,with implant 10′, the trailing end TE of the soft palate SP is urgedaway from the back of the throat and the soft palate SP is preventedfrom lengthening.

Placing the implants 10, 10′ under tension as in FIG. 1 provides therapyin that the tongue base TB and soft palate trailing end TE are retainedfrom movement toward the pharyngeal wall PW. In addition, at time ofinitial implantation or thereafter, a surgeon may obtain access toanchors 18, 18′ and further shorten the length of the elongated member12 (i.e., by pulling the member 12 through the bolt 18, 18′) to draw thetongue base or trailing end away from the pharyngeal wall to a newprofile. This is illustrated in FIG. 2 with the contracted profile shownin solid lines TB, TE and contrasted with the original profile shown inphantom lines TB′, TE′.

Referring to FIGS. 3 and 4, an alternative embodiment of the presentinvention is shown as a implant 10 a for the tongue T or implant 10 a′for the soft palate SP. As with the embodiments of FIGS. 1 and 2,implants 10 a, 10 a′ are functionally and structurally similar differingonly in size to facilitate placement in the tongue and soft palate,respectively. As a result, a description of implant 10 a will suffice asa description of implant 10 a′ (with similar elements similarly numberedwith the addition of an apostrophe to distinguish the implants 10 a, 10a′). Further, both implants 10 a, 10 a′ are shown implanted in the samepatient. Either or both implants could be implanted.

Implant 10 a includes a tissue engaging end 14 a and static end 16 a. Asin the embodiment of FIG. 1, the static end 16 a is secured to a hardpalate at the eyelet of an eyebolt 18 a secured to the jawbone JB.Again, as in the embodiment of FIG. 1, the tissue-engaging end 14 a maybe any material which encourages tissue in-growth and attachment totissue. An example of such a material may be PET or a felt material.

The tissue engaging end 14 a and the static end 16 a are connected by aresilient elongated member 12 a which may be in the form of a springmember such as nitinol or other member which may be stretched to createa bias urging ends 14 a, 16 a toward one another. Opposing the bias ofthe spring member 12 a is a bioresorbable material 20 positioned betweenthe tissue-engaging end 14 a and the bolt 18 a.

After placement of the implant 10 a within the tissue of the tongue andwith the end 14 a near the tongue base TB, the bio-resorbable material20 will later resorb into the tissue of the tongue T permitting end 14 ato be urged toward bolt 18 a by the resilience of the spring 12 a. Thisis illustrated in FIG. 4, where the contracted implant 10 a places thetissue of the tongue under tension and urging the tongue base TB awayfrom the pharyngeal wall PW. In FIG. 4, the contracted profile of thetongue base TB (and soft palate trailing end TE) is shown in solid linesand the original profile TB′ (TE′) is shown in phantom lines.

FIGS. 5-7 illustrate a still further embodiment for reducing the tonguebase TB. In this embodiment, a sheet 30 of tissue in-growth material(e.g., a sheet of felt with numerous interstitial space) is place in thetongue near the base TB. The sheet 30 is placed beneath the tonguesurface and parallel to the base TB substantially covering the area ofthe tongue base TB. Scarring from the material contracts over timeresulting in a reduction in the tongue base as illustrated in FIG. 6. Toheighten the amount of tongue base reduction, the sheet 30 may beimpregnated with a tissue reducing agent (e.g., a sclerosing agent).

FIGS. 9 and 10 illustrate a further variant of FIGS. 5-7. The implant 50includes three tissue in-growth pads 61, 62, 63. A nitinol bar 64connects the pads 61-63 in-line with pad 63 centrally positioned. Thebar 64 is pre-stressed to have a central bend shown in FIG. 10.Bio-resorbable sleeves 65, 66 hold the bar 64 in a straight line againstthe bias of bar 64 as in FIG. 9. The implant 50 is implanted as shown inFIG. 9 with the straight bar 64 parallel to the tongue base TB. Afterimplantation, tissue grows into pads 61-63. After the time period ofin-growth, the sleeves resorb as in FIG. 10. With the sleeves resorbed,the bar 64 bends to its pre-stressed shape. The tongue base moves withthe pad 63 to reposition the tongue base (illustrated in FIG. 10 as theshift from TB′ to TB).

FIG. 8 illustrates a still further embodiment of the invention forreducing the tongue base. Certain muscles of the tongue (particularly,the genioglossus muscles) radiate from the jawbone JB to the tonguesurface as illustrated by lines A in FIG. 8. Contacting implants 40identical to those in FIGS. 46 and 47 of U.S. Pat. No. 6,601,584 areplaced with a contracting axis (the axis between tissue in-growth ends14 a′—identical to ends 102b in FIGS. 46, 47 of the '584 patent) areplaced in the tongue in-line with the muscle radiating lines A.Alternatively, the contracting implant 40 may be of the constructionshown in FIGS. 48 and 49 of the '584 patent. As the implants contractover time, they urge the tongue from collapsing toward the pharyngealwall. In lieu of contracting implants, the elongated implants can bestatic implants such as implants shown in FIG. 11 of U.S. Pat. No.6,250,307 and labeled 20.

The foregoing describes numerous embodiments of an invention for animplant for the tongue and soft palate to restrict tissue movementtoward the pharyngeal wall. Having described the invention, alternativesand embodiments may occur to one of skill in the art. It is intendedthat such modifications and equivalents shall be included within thescope of the following claims.

1. A method for treating a condition of a patient's airway wherein thecondition is attributed at least in part to a spacing of a base of atongue from opposing pharyngeal wall surfaces in the airway; the methodcomprising: placing a tissue contractor within the tongue of thepatient, the contractor including a tissue-engaging end connected to amember; the tissue-engaging end formed of a tissue growth inducingmaterial to induce tissue in-growth into the tissue-engaging endfollowing implantation in the tongue; the placing including placing thetissue-engaging end within an interior of said tongue near the base ofthe tongue and with the member extending from the tissue engaging end toan end near a jaw bone of the patient; anchoring the end of the memberto the jaw bone for the member to resist movement of the tissue-engagingmember away from the jaw bone; and wherein the anchoring is performedafter at least partially securing the tissue-engaging end to the tissue.2. A method according to claim 1 wherein said anchoring includes pullingon the contractor near the jaw bone and securing the contractor to thejaw bone with the tongue under tension.
 3. A method according to claim 1wherein the condition is snoring.
 4. A method according to claim 1wherein the condition is sleep apnea.
 5. A method according to claim 1wherein the member is secured directly to the jaw bone.
 6. A methodaccording to claim 1 wherein the member is a suture material.
 7. Amethod according to claim 1 wherein the anchoring performed after aninitial implantation of the tissue contractor by accessing the memberand drawing on the member to draw the tissue-engaging end toward the jawbone and then anchoring the end of the member to the jaw bone.
 8. Amethod according to claim 1 wherein the member is a resilient material.9. An apparatus for treating a condition of a patient's airway whereinthe condition is attributed at least in part by a spacing of a base of atongue from opposing pharyngeal wall surfaces; the apparatus comprising:a tissue contractor dimensioned so as to be placed within the tongue,the contractor including a tissue-engaging end connected to a member; ananchor for securing the member in place near a jaw bone; thetissue-engaging end formed of a tissue growth inducing material toinduce tissue in-growth into the tissue-engaging end followingimplantation in the tongue; the member adapted to be accessed andsecured by the anchor to the jaw bone following initial implantation ofthe tissue contractor.
 10. An apparatus according to claim 9 wherein thecondition is snoring.
 11. An apparatus according to claim 9 wherein thecondition is sleep apnea.
 12. An apparatus according to claim 9 whereinthe member is adapted to be secured directly to the bony structure. 13.An apparatus according to claim 9 wherein the member is a suturematerial.
 14. An apparatus according to claim 9 wherein the member is aresilient material.